Effect of Preoperative Education Based on Roy Adaptation Model

Sponsor
Istanbul Medipol University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT05248529
Collaborator
(none)
78
1
2
5
15.7

Study Details

Study Description

Brief Summary

This research was conducted as a randomized controlled experiment to determine the effect of the education given by the Physiological Mode of Roy Adaptation Model in patients with hip or knee arthroplasty on physical adaptation and mobility.

Condition or Disease Intervention/Treatment Phase
  • Other: Education booklet
N/A

Detailed Description

The research was conducted between 01.11.2017 - 01.04.2018 at the Orthopedics and Traumatology Surgery Service of a private University Hospital in Istanbul.

In the study, the number of samples to be taken; the training, the training group control group mobility scale scores between The Observer at least 5% of the study considering that would make a difference, and power 80%, α=0.05 and power analysis adopted by participants for each group were calculated and it was determined that there should be at least 27.

The sample was composed of 78 individuals 41 experimental and 37 control. Patients' physical adaptation and mobility were evaluated using the Patient Mobility Scale and Observer Mobility Scale and Physical Adaptation Assessment Form.

Randomization of the study was achieved by planning patients who met the inclusion and non-inclusion criteria for training and control groups sequentially, without dividing them into hip or knee arthroplasty. In the randomization table, those with the number 1 are assigned to the training group.

Study Design

Study Type:
Interventional
Actual Enrollment :
78 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
The sample was composed of 78 individuals 41 experimental and 37 control. The intervention group was given practical training in accordance with the adaptation booklet prepared by the researcher. Patients' physical adaptation and mobility were evaluated using the Patient Mobility Scale and Observer Mobility Scale and Physical Adaptation Assesment Form. Data of the control and intervention groups were collected two times: preoperative and within 12 hours before the discharge.The sample was composed of 78 individuals 41 experimental and 37 control. The intervention group was given practical training in accordance with the adaptation booklet prepared by the researcher. Patients' physical adaptation and mobility were evaluated using the Patient Mobility Scale and Observer Mobility Scale and Physical Adaptation Assesment Form. Data of the control and intervention groups were collected two times: preoperative and within 12 hours before the discharge.
Masking:
Double (Participant, Investigator)
Primary Purpose:
Supportive Care
Official Title:
Effect of Preoperative Education Based on Roy Adaptation Model in Patients With Hip or Knee Arthroplasty on Physical Adaptation and Mobility
Actual Study Start Date :
Nov 1, 2017
Actual Primary Completion Date :
Jan 1, 2018
Actual Study Completion Date :
Apr 1, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: Intervention group

Within 12-24 hours before the surgery, the demonstrative education was given based on 'Hip Replacement Adaptation Booklet' and 'Knee Replacement Adaptation Booklet' to the patients in the intervention group.

Other: Education booklet
Hip/Knee Replacement Adaptation Booklet explains preoperative preparation, post-operative care practices, how to walk with walker, what needs to be done at home after discharge

No Intervention: Control gorup

Routine preoperative preparation training was performed to the patients in the control group.

Outcome Measures

Primary Outcome Measures

  1. Weight [5 days]

    weight in kilograms. It was used to determine the body mass index.

  2. height [5 days]

    height in meters. it was used to determine the body mass index.

  3. Body Mass Index [5 days]

    Body Mass Index is a simple calculation using a person's height and weight. The formula is BMI = kg/m2 where kg is a person's weight in kilograms and m2 is their height in metres squared.

  4. Systolic and diastolic blood pressure [5 days]

    Both systolic and diastolic blood pressure is measured in units of millimeters of mercury (mmHg). It was used to determine the blood pressure of patients before mobilization.

Secondary Outcome Measures

  1. The Observer Mobility Scale [5 days]

    1 point indicates that the activity can be performed independently without verbal warning and physical assistance, 5 points indicate that the patient cannot perform the activity independently despite the verbal warning and physical assistance. The lowest score that can be obtained from the scale is 4 and the highest score is 20.

  2. The Patient Mobility Scale [5 days]

    As a scale score, 1 indicates that the patient has no pain during the activity and the level of difficulty when moving is minimal, while 5 indicates that the patient's pain during the activity is unbearable and the level of difficulty is greatest. The lowest score that can be obtained from the scale is 8 and the highest score is 40.

Eligibility Criteria

Criteria

Ages Eligible for Study:
45 Years to 85 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

can read and write in Turkish A sufficient level of education to understand study procedures and training

Exclusion Criteria:

hospitalized due to fracture mental disability neurological disease undergone the same operation before received similar training before

Contacts and Locations

Locations

Site City State Country Postal Code
1 Yeditepe University Hospital Istanbul Turkey

Sponsors and Collaborators

  • Istanbul Medipol University Hospital

Investigators

  • Study Director: Merve Ozsoy Durmaz, Medipol University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Merve Ozsoy Durmaz, MSc, Research Assistant, Istanbul Medipol University Hospital
ClinicalTrials.gov Identifier:
NCT05248529
Other Study ID Numbers:
  • mozsoy
First Posted:
Feb 21, 2022
Last Update Posted:
Mar 8, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Merve Ozsoy Durmaz, MSc, Research Assistant, Istanbul Medipol University Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 8, 2022